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Not Yet Recruiting NCT07791875

AI-Based Analysis of Port Catheter Tip Position

Conditions: Vascular Access Devices

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Bagcilar Training and Research Hospital

Location: Bagcilar Training and Research Hospital Bağcılar Istanbul

Summary

This prospective, single-center observational study will evaluate the performance of an artificial intelligence (AI)-based automated image-analysis method that will be developed, internally tested, and locked before prospective enrollment. The method will estimate the position of totally implantable venous access port catheter tips in adults undergoing right internal jugular vein port implantation as part of routine care. The automated estimate will be compared with a prespecified manual measurement method. Reference measurements of the catheter tip and the cavoatrial junction will be obtained from clinically indicated chest computed tomography images when both structures are visible. No additional chest radiography or computed tomography will be performed for research purposes, and the automated output will not guide catheter placement or alter clinical decisions. The primary performance measure will be the mean absolute error of the automated estimate in the prospective cohort.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older. * Planned placement of a totally implantable venous access port through the right internal jugular vein as part of routine clinical care. * Availability of a suitable pre-implantation chest radiograph obtained as part of routine clinical care. * Availability of a clinically indicated post-implantation noncontrast chest computed tomography examination. * Absence of documented catheter manipulation or revision before the selected post-implantation computed tomography examination. * Provision of written informed consent. Exclusion Criteria: * Age younger than 18 years. * Cancellation of the routine clinical port implantation plan. * Planned or performed port placement through a venous access route other than the right internal jugular vein. * No suitable pre-implantation chest radiograph available for study assessment. * Advanced thoracic deformity or mediastinal distortion precluding the required study measurements. * Inability or unwillingness to provide written informed consent.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07791875). StuddyBuddy aggregates publicly available trial information.